Agitation-Induced Aggregation of Lysine- and Interchain Cysteine-Linked Antibody-Drug Conjugates.

antibody–drug conjugate(s) (ADC) conjugation developability high-throughput technology(s) monoclonal antibody(s) physical stability protein aggregation

Journal

Journal of pharmaceutical sciences
ISSN: 1520-6017
Titre abrégé: J Pharm Sci
Pays: United States
ID NLM: 2985195R

Informations de publication

Date de publication:
07 Dec 2023
Historique:
received: 24 09 2023
revised: 01 12 2023
accepted: 02 12 2023
medline: 10 12 2023
pubmed: 10 12 2023
entrez: 9 12 2023
Statut: aheadofprint

Résumé

Drug conjugation to an antibody can affect its stability, which depends on factors such as the conjugation technique used, drug-linker properties, and stress encountered. This study focused on the effects of agitation stress on the physical stability of two lysine (ADC-K) and two interchain cysteine (ADC-C) conjugates of an IgG

Identifiants

pubmed: 38070776
pii: S0022-3549(23)00511-7
doi: 10.1016/j.xphs.2023.12.003
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

Copyright © 2023. Published by Elsevier Inc.

Auteurs

Florian Johann (F)

Friedrich-Alexander University (FAU) ErlangenNürnberg, Department of Pharmaceutics, Freeze Drying Focus Group (FDFG), Cauerstraße 4, 91058 Erlangen, Germany; Merck KGaA, Global CMC Development, Frankfurter Straße 250, 64293 Darmstadt, Germany.

Steffen Wöll (S)

Merck KGaA, Global CMC Development, Frankfurter Straße 250, 64293 Darmstadt, Germany.

Matthias Winzer (M)

Merck KGaA, Global CMC Development, Frankfurter Straße 250, 64293 Darmstadt, Germany.

Henning Gieseler (H)

Friedrich-Alexander University (FAU) ErlangenNürnberg, Department of Pharmaceutics, Freeze Drying Focus Group (FDFG), Cauerstraße 4, 91058 Erlangen, Germany; GILYOS GmbH, Friedrich-Bergius-Ring 15, 97076 Würzburg, Germany. Electronic address: info@gilyos.com.

Classifications MeSH